An observational study in Vision Impairment and Eye Diseases, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
The Proactive Ophthalmic Examination Cohort of Older Adults is a prospective cohort study recruiting community-dwelling older adults aged 65 years or older. Through comprehensive assessment of demographic profiles, medical histories, and ocular structural and functional parameters, alongside systematic collection of ophthalmic and systemic clinical data and biological specimens, we will establish a multidimensional, high-quality ocular health database encompassing demographic characteristics, socioeconomic factors, lifestyle variables, ocular disease risk factors, subjective ocular symptoms, objective examination findings, and biospecimens. The study will investigate the onset and progression patterns of ocular diseases, associated risk factors, and mechanisms of ocular aging in older populations, while simultaneously providing normal-controlled clinical and genomic data for other clinical studies on eye diseases. Furthermore, leveraging algorithmic innovation and artificial intelligence technologies, we will develop a personalized risk prediction and monitoring platform for age-related eye diseases, enhancing early screening and diagnostic capabilities and advancing precision medicine for ocular health in older adults.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population comprises community-dwelling older adults aged 65 years or older. Participants are recruited on a voluntary basis and are willing to undergo comprehensive annual ophthalmic examinations throughout the follow-up period. Individuals who are unable to complete required systemic or ophthalmic assessments due to frailty or poor general health are excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Aged 65 years or older
Exclusion Criteria:
Incidence of Visual Impairment
Visual impairment is defined as best-corrected visual acuity (BCVA) worse than 20/40 in either eye, assessed using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart at each annual visit. Incidence is calculated as the number of new cases per 100 person-years among participants free of visual impairment at baseline. chart at each visit.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Change from Baseline in Best-Corrected Visual Acuity (BCVA)
Best-corrected visual acuity (BCVA) is measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart at each annual visit. Change is calculated as the difference between each follow-up measurement and the baseline value obtained at enrollment.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Incidence of Age-Related Cataract
Incidence of age-related cataract, defined as the presence of lens opacity in one or both eyes, was graded using the Lens Opacities Classification System III (LOCS III). New cases are identified among participants who are free of cataract at baseline.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Incidence of Age-Related Macular Degeneration (AMD)
Incidence of AMD, defined as the new development of AMD in one or both eyes, was assessed by fundus photography and optical coherence tomography (OCT) at each annual visit.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Incidence of Diabetic Retinopathy (DR)
Incident diabetic retinopathy is defined among participants with diabetes mellitus and no diabetic retinopathy at baseline as the first detection of any definite diabetic retinopathy, indicated by an Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale level ≥20 in either eye on standardized annual fundus photography.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Incidence of Myopia-Related Fundus Changes
Incident myopia-related fundus changes are defined among highly myopic eyes without the specified fundus changes at baseline as the first detection during follow-up of lacquer cracks, myopic choroidal neovascularization, patchy chorioretinal atrophy, or macular atrophy, identified by standardized fundus photography and optical coherence tomography (OCT) at annual visits. High myopia was defined as an axial length ≥26.0 mm or spherical equivalent ≤-6.00 diopters at baseline.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Change from Baseline in Montreal Cognitive Assessment (MoCA) Score
Global cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), a validated screening tool covering visuospatial/executive function, naming, memory, attention, language, abstraction, and orientation. Change is calculated as the difference between each annual follow-up score and the baseline score obtained at enrollment.
Time frame: Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Proportion of Participants Reporting Visual Disturbances
The proportion of participants reporting visual disturbances, including but not limited to photopsia, floaters, diplopia, and metamorphopsia, is collected via a standardized structured questionnaire at each annual visit.
Time frame: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, and Year 10
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Feb 2033, 119 months after the start.
Of 51 non-industry observational studies under Vision Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 119 months is above that.
Counting every sponsor, half of 58 studies reached it within 23 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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Zhongshan Ophthalmic Center, Sun Yat-sen University →